Senior Process Development Engineer - Medical Devices

Open Scientific; Town of Florida (NY); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Open Scientific in the United States seeks a Manufacturing Process Engineer to drive design transfer and scalable production of medical devices, including aortic stent grafts. You will lead process development, validation planning and implement efficient manufacturing systems.

The role requires hands-on experience with DFMEA/PFMEA, IQ/OQ/PQ, and the ability to translate product designs into robust manufacturing processes while ensuring quality, cost control and safety across operations.

Formación

• Experience in manufacturing processes and quality considerations.
• Knowledge of IQ/OQ/PQ protocols and reports.
• Experience with design transfer and validation planning.

Responsabilidades

• Design, evaluate, implement and monitor processes and operating systems for the manufacture aortic stent grafts
• Develop and implement new mfg processes, execute process validations such as IQ, OQ, PQ protocols and reports
• Lead the design transfer phase including product development, validation planning, design for manufacturability and assembly, Design of Experiments, process capability analysis, etc.
• Conduct risk analysis including DFMEA, PFMEA and create/maintain necessary documentation.
• Support the conversion of small-scale processes into commercially viable large-scale operations.
• Monitor and improve the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel.
• Other various responsibilities and projects, as necessary

Conocimientos

Process design

Process validation

DFMEA

PFMEA

Manufacturing planning

Quality systems

Descripción del empleo

Open Scientific in the United States seeks a Manufacturing Process Engineer to drive design transfer and scalable production of medical devices, including aortic stent grafts. You will lead process development, validation planning and implement efficient manufacturing systems.

The role requires hands-on experience with DFMEA/PFMEA, IQ/OQ/PQ, and the ability to translate product designs into robust manufacturing processes while ensuring quality, cost control and safety across operations.